An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A total of 4164 participants were screened and 4065 were randomized

Reporting Groups

Description

qHPV Vaccine in Base Study

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Placebo in Base Study

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

EXT1: Placebo in Base Study

Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.

Participants were followed to EXT1 Month 7.

EXT1: Incomplete qHPV Regimen in Base Study

Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).

Participants were followed to EXT1 Month 7.

LTFU (EXT2): Early Vaccination Group

Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).

LTFU (EXT2): Catch-up Vaccination Group

Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).

Participant Flow for 4 periods

Period 1: Base Study Vaccination Period

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

LTFU (EXT2): Early Vaccination Group

LTFU (EXT2): Catch-up Vaccination Group

STARTED

2032

2033

0

0

0

0

Vaccinated

2025

2030

0

0

0

0

COMPLETED

1818

1814

0

0

0

0

NOT COMPLETED

214

219

0

0

0

0

Randomized Not Vaccinated

7

3

0

0

0

0

Adverse Event

2

4

0

0

0

0

Lost to Follow-up

111

112

0

0

0

0

Protocol Violation

2

3

0

0

0

0

Withdrawal by Subject

64

69

0

0

0

0

Uncooperative

2

2

0

0

0

0

Moved

20

21

0

0

0

0

Site Terminated

1

0

0

0

0

0

Other

2

2

0

0

0

0

Subject Incarcerated

2

2

0

0

0

0

HIV positive

1

1

0

0

0

0

Period 2: Base Study Follow-up Period

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

LTFU (EXT2): Early Vaccination Group

LTFU (EXT2): Catch-up Vaccination Group

STARTED

1822 [1]

1821 [2]

0

0

0

0

COMPLETED

1487

1479

0

0

0

0

NOT COMPLETED

335

342

0

0

0

0

Adverse Event

3

10

0

0

0

0

Lost to Follow-up

232

226

0

0

0

0

Withdrawal by Subject

53

64

0

0

0

0

Moved

41

36

0

0

0

0

Other

2

0

0

0

0

0

Protocol Violation

1

0

0

0

0

0

Uncooperative

3

4

0

0

0

0

Subject Incarcerated

0

2

0

0

0

0

[1]

4 subjects who did not receive 3 doses of vaccine in base study continued into the Follow-up Period

[2]

7 subjects who did not receive 3 doses of placebo in base study continued into the Follow-up Period

Period 3: Extension 1

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

LTFU (EXT2): Early Vaccination Group

LTFU (EXT2): Catch-up Vaccination Group

STARTED

0

0

1098 [1]

16 [1]

0

0

COMPLETED

0

0

1041

15

0

0

NOT COMPLETED

0

0

57

1

0

0

Adverse Event

0

0

2

0

0

0

Lost to Follow-up

0

0

35

0

0

0

Withdrawal by Subject

0

0

13

1

0

0

Other

0

0

4

0

0

0

Moved

0

0

3

0

0

0

[1]

Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

qHPV Vaccine in Base Study

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Placebo in Base Study

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Total

Total of all reporting groups

Baseline Measures

qHPV Vaccine in Base Study

Placebo in Base Study

Total

Overall Participants Analyzed [Units: Participants]

2032

2033

4065

Age [Units: Years]Mean (Standard Deviation)

20.6 (2.0)

20.5 (2.0)

20.5 (2.0)

Age [1] [Units: Years]Median (Full Range)

20
(16 to 26)

20
(15 to 27)

20
(15 to 27)

[1]

Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.

Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)

Measure Description

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.

Time Frame

Base study: through Day 5 after any vaccination

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.

Reporting Groups

Description

qHPV Vaccine in Base Study

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Placebo in Base Study

The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the Base Study encompassed Month 7 through Month 36.

Measured Values

qHPV Vaccine in Base Study

Placebo in Base Study

Participants Analyzed

2020

2029

Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) [Units: Participants]Count of Participants

25

20

No statistical analysis provided for Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)

LTFU (EXT2): Number of Participants With Vaccine-Related SAEs [ Time Frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine ]

LTFU (EXT2): Number of Participants Who Died [ Time Frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine ]

Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM) [ Time Frame: Base study: through Month 36 ]